This team ensures Pfizer'sClinical Study Report(CSR)managementmeetsglobal agency standards and manages regulatory reporting, dossier development, and submission activities for Global Regulatory & International Operations (RIO).Members in the teamoverseeandmanageend-to-end lifecycledevelopmentof CSRto support Pfizer's global drug registration and approval processes, including submission, publishing, and archiving of related reports and documents.

Associate

• Lead the coordination,compilation, quality control,approvaland post-approval processes associated with development of Pfizer global CSRs

• Create CSRmockupsin System and populate document templates

• Project manage CSR compilation,approvaland publishing activities

• Execute submission readyQuality Control (QC)on CSR components and structure

• Communicate with function linesregardingissues with CSR components and seek resolutions

• Seek approval from signatories onfinalizedCSRs and update clinical trial registry with CSR milestone status

• Prepare investigators declaration packages for distribution to the coordinating investigator

• Prepare study data packages required for distribution to studyPrincipal Investigators(PIs)

• CoordinatePublic Disclosure Synopsis(PDS)andPlain Language Summary(PLS)activities

• Publishes the approved report into Pfizer standardsubmission-readyandregulatorycompliant package,andcontributes to submissionpackage

• Files thereport toTrial Master Files(TMF)systemto meetregulatory requirements

• Monitor public mailbox

• Provide ongoing quality reviews and process improvement suggestions to the work group or project team, supporting continuous enhancement of CSR coordination practices

Work Location Assignment: Hybrid

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs